Pilot Project for a National Monitoring System for Major Adverse Effects of Medication Use During Pregnancy and Lactation

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form No number Follow-up Breastfeeding Questionnaire	Form	New	Repair queued
Form Nonumber Initial Breastfeeding Questionnaire	Form	New	Repair queued
Form No number Follow-up Infant Questionnaire	Form	New	Repair queued
Form No number Initial Infant Questionnaire	Form	New	Repair queued
Form No number Follow-up Pregnancy Questionnaire	Form	New	Repair queued
Form No number Initial Pregnancy Interview	Form	New	Repair queued
Form No number Enrollment Interview	Form	New	Repair queued
Form No number Consent Form	Form	New	Available
Form No number Tracking Form	Form	New	Repair queued
Form no number Telephone Script for Permission to be Contacted when Counselor is not the Study Coordinator	Form	New	Repair queued
AA_Supp_Statement_PART_B_Octo_08_FINAL.doc	Supporting Statement B	Uploaded 2008-11-03	Repair queued
Attachment_I_Research_Determination.doc	Supplementary Document	Uploaded 2008-11-03	Repair queued
Attachment_H2.pdf	Supplementary Document	Uploaded 2008-11-03	Repair queued
Attachment_H1.pdf	Supplementary Document	Uploaded 2008-11-03	Repair queued
Attachment F.doc	Supplementary Document	Uploaded 2008-11-03	Repair queued
Attachment E_ScheduleofInterviews.doc	Supplementary Document	Uploaded 2008-11-03	Repair queued
Attachment C3 102108.doc	Supplementary Document	Uploaded 2008-11-03	Repair queued
Attachment B_60Day.pdf	Supplementary Document	Uploaded 2008-11-03	Repair queued
Attachment C2b 102108.doc	Supplementary Document	Uploaded 2008-11-05	Repair queued
Attachment C1b 102108.doc	Supplementary Document	Uploaded 2008-11-05	Repair queued
AA_Supp_Statement_PART_A_Oct_31_08_FINAL.doc	Supporting Statement A	Uploaded 2008-11-03	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
187730	Follow-up Breastfeeding Questionnaire	Form	New
187729	Initial Breastfeeding Questionnaire	Form	New
187728	Follow-up Infant Questionnaire	Form	New
187727	Initial Infant Questionnaire	Form	New
187726	Follow-up Pregnancy Questionnaire	Form	New
187725	Initial Pregnancy Interview	Form	New
187724	Enrollment Interview	Form	New
187723	Consent Form	Form	New
187722	Tracking Form	Form	New
187721	Telephone Script for Permission to be Contacted when Counselor is not the Study Coordinator	Form	New

ICR Details

OMB Control No:	ICR Reference No: 200901-0920-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Pilot Project for a National Monitoring System for Major Adverse Effects of Medication Use During Pregnancy and Lactation
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 04/22/2009
	Date Received in OIRA: 01/06/2009
Terms of Clearance: This ICR is being withdrawn consistent with the agency's request.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The US has no early warning system for major adverse pregnancy or infant outcomes related to medication exposures. The US FDA collects reports of adverse health events associated with medication use, the the length of time between many pregnancy exposures and outcomes makes underreporting a limitation of this system for monitoring pregnancy outcomes. Because use of individual medications among child-bearing women can be low, it can takes years for case-control studies and birth defects surveillance systems to identify adverse effects of medications after they are marketed. Teratology Information Services (TIS) throughout the US and Canada use specialists to provide phone consultation, risk assessment, and counseling about environmental exposures during pregnancy and breastfeeding - including prescription and over-the-counter medications, herbal preparations, and dietary supplements - to women and healthcare providers. They have direct contact with pregnant and breastfeeding women, and the women contact TIS specifically to obtain information about these exposures. TIS are in a unique position to monitor the effects of medication use during pregnancy and lactation on pregnancy outcomes and maternal and infant health. Development of a national monitoring system for major adverse effects of medication use during pregnancy and lacation through TIS will contribute to the following health outcomes: Improved decision-making by pregnant and breastfeeding women and their healthcare providers about the safe use of medications, improved maternal health through the safe use of medications during pregnancy and breastfeeding, and improved infant health through identification of medications the can result in major adverse effects.

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Authorizing Statute(s): PL: Pub.L. 42 - 241 301 Name of Law: Public Health Service Act
   PL: Pub.L. 32 - 247 317C Name of Law: Children's Health Act of 2000
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 65737	11/23/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 67517	11/14/2008
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

table that charts list of burden

IC Title	Form No.	Form Name
Telephone Script for Permission to be Contacted when Counselor is not the Study Coordinator	no number	Telephone script when counselor is not study coordinator
Tracking Form	No number	Tracking form
Consent Form	No number	Consent form for Pregnant Women
Enrollment Interview	No number	Enrollment Interview
Initial Pregnancy Interview	No number	Initial pregnancy questionnaire
Initial Breastfeeding Questionnaire	Nonumber	Initial Breastfeeding Questionnaire
Follow-up Breastfeeding Questionnaire	No number	Follow-up Breastfeeding Questionnaire
Follow-up Pregnancy Questionnaire	No number	Follow-up Pregnancy Questionnaire
Initial Infant Questionnaire	No number	Initial Infant Questionnaire
Follow-up Infant Questionnaire	No number	Follow-up Infant Questionnaire

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $87,500

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/06/2009

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